Comparison · NCT02129699-sae
None, Standard Chemotherapy Only vs Standard Chemotherapy + Denosumab: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. None, Standard Chemotherapy Only vs Standard Chemotherapy + Denosumab: serious adverse events. Trial comparisons, record NCT02129699-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02129699-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.38 | 0.323 | 0.441 | wilson | |
| Risk in group 2 | 0.533 | 0.472 | 0.593 | wilson | |
| Risk difference, group 1 minus group 2 | -0.152 | -0.235 | -0.0663 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.714 | 0.588 | 0.867 | log | |
| Odds ratio, group 1 over group 2 | 0.538 | 0.379 | 0.765 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on None, Standard Chemotherapy Only than on Standard Chemotherapy + Denosumab | 6.56 | 4.25 | 15.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | None, Standard Chemotherapy Only | 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.~Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.~None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):~Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 | 97 | 255 | EG000 |
| Group 2 | Standard Chemotherapy + Denosumab | 4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.~Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.~Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months). | 138 | 259 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
Source ClinicalTrials.gov
Trial
- Title
- Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
- NCT number
- NCT02129699
- Phases
- PHASE3
- Conditions
- Lung Cancer Non-small Cell Stage IV
- Interventions
- Denosumab, None, standard chemotherapy only
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Results first posted
- 2024-04-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02129699?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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